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Today, the US government announced that it's reached a $3 billion settlement with GSK regarding several long-standing investigations. We cooperated with the Department of Justice in these investigations and, in November 2011, announced an agreement in principle with the Government to conclude these investigations.

As of today, the final settlement is complete. Although the activities covered by this settlement largely occurred years ago, we must learn from the past. And we have. In my opinion, the picture of our company portrayed in these charges does NOT reflect who we are today. We've always been a good company--rooted in values. But the expectations of our industry--and the people who work in it--have changed.

In the last few years, we've publicly demonstrated--in our words and actions--who we are as a company. That we wish to live up to and exceed the expectations of those who watch us and work with us. Today, we are reaffirming our commitment to do just that.

We've changed the way we promote our products and work with our customers. Going forward we'll institute further changes, including greater standardization in our operations and additional compliance training. In fact, we started making changes before we were asked by the government, including compensating our sales representatives on the value they bring to their customers, not on sales targets. We're making our medicines and vaccines more available and affordable to people who need them, regardless of where they live or their ability to pay. These are just some of the ways we've changed the way we work to focus on bringing the right medicines to the right patients wherever they happen to be.

GSK is a company of 97,000 people who dedicate their lives to delivering quality medicines that benefit millions of people. Is there more we can do? Absolutely--and we're always looking to improve.

Today marked a significant event for Neglected Tropical Diseases (NTDs)--a call to arms of sorts.

Thirteen pharmaceutical companies; the US, UK, and UAE governments; the Bill & Melinda Gates Foundation; the World Bank; and other global health organizations announced a new, coordinated push to work with the World Health Organization and endemic countries to fight 10 NTDs by 2020. 

In London today, I participated in a meeting of partners who came together to stand united in this fight against lymphatic filariasis (elephantiasis), river blindness, blinding trachoma, intestinal parasites, schistosomiasis, leprosy, Guinea worm, visceral leishmaniasis, sleeping sickness, and Chagas disease. These are diseases that threaten more than one billion people in developing countries, causing tremendous illness, disability and death. They tax a heavy burden on already over-stretched and under-resourced health systems; yet they are diseases that we have the tools to fight! 

Speaking on behalf of all the industry partners, GSK's CEO, Sir Andrew Witty, announced expanded and extended donations of medicines for control, elimination, or eradication of these 10 diseases. Collectively, our industry will supply all the drugs needed through the end of the decade.

In addition to donation of necessary medicines, pharma partners pledged to advance research and development to find new and improved treatments for NTDs. 

I have worked with GSK's albendazole donation program for over 10 years, and today made me even prouder to be a part of this global effort. All too often in my travels to endemic countries, I've seen children facing multiple diseases: a child carrying a heavy intestinal worm infection, for example, also living in fear of severe disfigurement from LF. It therefore makes good sense for us to work together. With flexibility and eagerness, we can and will make a marked difference in the communities threatened by these once neglected diseases.

On August 20, we blogged about our July 28 communications with clinical trial investigators in TIDE, a prospective, cardiovascular outcome study comparing Avandia  (rosiglitazone) to Actos  (pioglitazone) as mandated by the U.S. Food and Drug Administration (FDA).  That July 28 communication summarized the two-day FDA Advisory Committee meeting (July 13-14) on the cardiovascular safety of Avandia. There is an update from FDA regarding the TIDE trial which we felt should be shared for the sake of transparency.

Since the post was published, GSK has received a request from the FDA that the company inform the TIDE Steering Committee to "re-issue a letter"  for trial participants that was sent prior to GSK's July 28, 2010 summary for investigators, Institutional Review Boards and Ethics Commitees  involved in the TIDE trial. 

The FDA wrote GSK that the July 16 letter to trial participants did "not accurately capture the results on all the voting questions posed to the advisory committee panel at this meeting. There is an overemphasis on the mortality findings that appears to dismiss the risk of ischemic cardiovascular events, particularly between rosiglitazone and pioglitazone.  Consequently, this information does not fully inform participants of the potential risks of the different treatments in the TIDE trial."

GSK is complying with this recent FDA request.

Several facts are left unclear in the New York Times article entitled "Glaxo Memo on Avandia Questioned." 

The FDA mandated the TIDE trial, and the Agency asked GSK to write a summary of a two-day Advisory Committee hearing (July 13-14) and the FDA's subsequent notification to GSK that the TIDE trial was being placed on partial clinical hold. The summary was directed to a very specific audience:  investigators (the doctors doing the trials), Institutional Review Boards and Ethics Committees that oversee the ongoing TIDE clinical trial with Avandia.

Specifically, the FDA asked: "Within one week, you must inform all investigators, institutional review boards (IRBs) and ethic committees involved in the TIDE trial of the new safety data/information presented at the FDA Advisory Committee meeting held on July 13 and 14, 2010.  Please also include information regarding the deliberations, recommendations and voting from the panel members regarding the specific questions posed at the meeting.  This information may be utilized by investigators and IRBs to update the informed consent document for patients currently enrolled in the TIDE trial.  In addition, a written summary of this information/data should be submitted to your IND file."

GSK agreed the letter was important for investigators so that they could inform patients in the TIDE trial about the Advisory Committee meeting.  GSK then prepared the letter, which the chair of the TIDE Steering Committee approved. The letter was not a general outreach to physicians.

The summary was to be brief (9.5 pages here) and sent quickly (sent within one week). To provide some context, the transcripts of the meeting total 934 pages. Written briefing materials for the committee had been posted by FDA online and the GSK letter alerted investigators to the documents and provided a link to available materials. Contrary to the NY Times report, the summary mailed by GSK provided full detail on the questions posed to the Advisory Committee and the vote on each.

The summary outlined presentations by FDA agency personnel, GSK and others as well as major discussion points. A brief summary--which is what was required--certainly cannot cover the entirety of the briefings or hearing presentations but both GSK and the chair of the TIDE steering committee agreed that the summary reflected the science and data discussed at the advisory committee meeting. A copy of the letter is available for public review.

As we have in past natural disasters, GSK is working closely with partner humanitarian organizations to assist in the response to the terrible floods in Pakistan.  And that includes our staff who live and work in that country.  The note below was posted on our internal company website:

GSK steps up response for Pakistan flood relief

The situation in Pakistan is changing rapidly as floods have swept down the country and even more rains are expected in the coming weeks.  As the needs are emerging, GSK Pakistan is stepping up its response, working with a number of organizations in all flood-affected areas to provide shelter, clean water, healthcare and food.

On August 18, GSK made a contribution of £100,000 (roughly $150,000) to support agencies which are organizing food and medicines distribution, including funds specifically earmarked for the World Food Programme (WFP), the International Red Crescent (IRC) and medicines to the provincial government agencies reaching some of the remotest areas.  

Despite huge logistical challenges, GSK Pakistan's medicines have been among the first to reach many marooned villages. Our donated medicines have been distributed by a variety of relief aid agencies such as the Abaseen Foundation, the first to reach 20,000 people in the remote Swat valley, and International Medical Corps (IMC) which rapidly mobilized six medical teams to the Khyber Pakhtunkhwa Province in the immediate aftermath of the floods.  With a temporary halt in the rains, people have been able to make their way to the mobile clinics set up by IMC, which have conducted over 6,000 health consultations, treating some of the most pressing cases such as acute diarrhea, skin disease and acute respiratory infections.     

GSK Pakistan has also provided medicines to several other relief agencies reaching areas further south.  For example, the Pakistan Medical Association (PMA), working in Sindh, where widespread destruction has displaced an estimated 3.5 million people from their homes, and also the Pakistan's National Health Emergency Preparedness and Response Centre (HEPR) and The National Commission for Human Development (NCHD), which has already reached over 80,000 patients in mobile medical camps in all the flood affected districts.

In line with GSK's principles for humanitarian support, we are continuing to evaluate the ongoing healthcare needs and will provide further support at the request of the Ministry of Health and local/international NGOs who are involved in the recovery efforts. 

GSK Pakistan employees have been making contributions in cash and in kind. A number of international appeals have been launched.  Employees can make a personal donation via the following website links.

International Federation of Red Cross and Red Crescent Societies Appeal

International Medical Corps has been operating in Pakistan since 1984, providing primary health care services and water/sanitation facilities to displaced Pakistanis as well as to Afghan refugees in the frontier areas.

US-based employees can send contributions to the American Red Cross, Box 37295, Washington, DC 20013, and earmark gifts for the Pakistan Floods Disaster.

Today's inflammatory New York Times story, "Diabetes Drug Maker Hid Test Data on Risks, Files Indicate," is based on selected documents provided to plaintiffs' attorneys in litigation which were then also provided to the Senate Finance Committee.  Selectively making public a cherry-picked few documents from over 14 million pages in litigation presents an incomplete and misleading picture of the safety of Avandia and company conduct.

The New York Times focuses on one small study that did not involve Avandia.  GSK conducted this study on a competitor drug looking at its effects on LDL cholesterol and triglycerides; it was not a head-to-head study directly comparing Avandia and the competitor, pioglitazone, as reported by the New York Times.  GSK conducted the study to help inform a decision of whether or not to do a head-to-head trial between Avandia and the competitor.  The results of this competitor drug study were consistent with the FDA-approved drug label for pioglitazone, and therefore did not contribute any clinically significant new information.  Because the study offered no new clinically relevant information and did not involve a GSK drug, GSK did not publish the data. 

Two studies comparing Avandia and another drug, glyburide, are referenced by the New York Times; it's important to note that GSK submitted this data to the FDA in 1999 and made those data available publicly on the company's Clinical Study Register.

GSK has worked consistently--before and after Avandia was approved in 1999 by the FDA--to add to our understanding of the cardiovascular safety of the medicine.  As far back as late 2001, as part of the company's ongoing pharmacovigilance program, GSK conducted a review of Avandia and heart attack.  At that time, the data identified no signal of an increased risk for heart attacks associated with Avandia.  GSK informed the FDA of this internal review and described its results in a Periodic Safety Update Report. 

Subsequently and to date, over 200 studies and protocols on Avandia--including those that contain data on heart attack--have been made publicly available on the company's clinical trial register.  In fact, Avandia is the most widely studied oral anti-diabetic medicine for type 2 diabetes, which means we know more about both the safety and the efficacy of this medicine than any other oral drug for diabetes.  When you look at all of the clinical trial data available, we believe the data show that Avandia has an ischemic cardiovascular safety profile comparable to the most widely prescribed oral diabetes medicines.  GSK has been--and remains--committed to and diligent in providing its safety data on Avandia to the FDA, and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.

Here is our statement on the Senate Finance Committee press release issued today.

And here is our legally required fair balance.

Important Safety Information

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

• Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

• Take insulin or nitrate medicines.

• Have a type of diabetic eye disease called macular edema.

• Have liver problems or had liver problems while taking REZULIN® (troglitazone).

• Are pregnant or planning to become pregnant.

• Are breastfeeding or planning to breastfeed.

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes.

For more information about AVANDIA, please see Medication Guide

(http://www.avandia.com/type-2-diabetes-medication-guide.html) and full Prescribing Information, including Boxed WARNING (http://us.gsk.com/products/assets/us_avandia.pdf).

There has been continued focus today in the healthcare news media, on health blogs and Twitter on the US Senate Finance Committee's report regarding GSK and our diabetes medicine Avandia.   Patients, doctors, media and others are asking questions about our company and the safety of our medicine.  Looking at a lot of the content and commentary, it is clear that many people are only getting part of the story--or worse, the wrong message entirely.

In particular, misleading headlines stating that "FDA Report Advises Avandia be Pulled from the Market," were re-Tweeted dozens of times; other commentary we found to be more balanced including this piece in Forbes gained less attention.   According to their own statement this afternoon, "FDA is now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time."  FDA further advised doctors:

When prescribing rosiglitazone, healthcare professionals should follow the recommendations in the drug label. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional.

FDA has called for a public advisory panel meeting this July and we look forward to working with FDA and the panel to provide any further information they request.

In addition to the FDA's advice patients and their doctors may be interested in the perspective of organizations including the Endocrine Society and the American Heart Association. 

We will continue to post new information and clarifications regarding this issue as we believe necessary, but hope to get back to using this space to focus on "More than Medicine."

We issued a statement strongly challenging the characterization of our medicine and our company.  And while it remains our pledge not to promote GSK products on this blog, we do want to address the accusation that our company has somehow acted inappropriately, and worse, endangered patients' health.  We also want to provide some important information that media reports do not include.

First, let's address this idea that the FDA is calling for withdrawal of Avandia.

The FDA itself has not issued new data or called for withdrawal. Instead, the document referenced in the media is a report from 2008 by two doctors who work at the FDA, resurrecting a call they made the year before--employing statistics they used at that  time (e.g. 83,000 excess heart attacks between 1999 and 2007)--to say that Avandia has harmed patients. But importantly, these same claims and the call for withdrawal were considered--with all the scientific data available at that time--by an independent panel of scientific experts in 2007.  That independent panel voted 22-1 to recommend that Avandia remain available to patients for the treatment of Type 2 diabetes.  The FDA considered this recommendation and also decided, based on its own review of the science, that Avandia remain available to patients for the treatment of Type 2 diabetes. In the years since the FDA made its decision to keep Avandia on the market, seven clinical studies do not show an increased risk.

If we talk numbers, we need to talk about those clinical trials. Those seven large, prospective, randomized, clinical trials have completed and reported data on the cardiovascular safety of Avandia.  These types of scientific trials are the gold standard for gathering and evaluating scientific data.  None of these randomized clinical trials showed a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events, like angina.

Second, let's address the idea that GSK did not share information the company had about the medicine's safety. 

Again, we disagree with that assertion.  Any fair examination of the company's record will show that GSK has been transparent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways. 

At the time Avandia was approved by the FDA to be used along with diet and exercise by type 2 diabetes patients, GSK and regulatory agencies agreed it was important to develop the highest level of scientific evidence to assess the medicine's benefit-to-risk profile for type 2 diabetes, a chronic disease. Accordingly, GSK has followed a rigorous program of scientific analysis to research both the safety and benefits of Avandia. GSK promptly started the clinical studies it promised the FDA it would do.

GSK has reported its study findings to regulatory agencies, including the FDA, based on emerging clinical trial results and other data regarding the safety profile of Avandia. GSK gave its meta-analyses to the FDA and posted them on its web.  Dr. Nissen, however, told Congress at the June 6, 2007 hearing that he gave his analysis to members of Congress rather than the FDA.

GSK also made studies and other data regarding Avandia available to scientists in the public domain in a variety of ways, including publication and posting data on the company's Clinical Trial Register. Dr. Nissen gathered data for his analysis from GSK's Clinical Trial Register, so the GSK data was obviously available publicly.

In addition, GSK has updated the product information for Avandia over the years to add cardiovascular and other safety information as new data has become available.

Third, let's address the idea that GSK intimidates scientists to squelch scientific debate.

GSK welcomes and supports open and independent scientific debate about its medicines.  GSK does not condone any effort to silence such debate.  As part of the process of scientific debate about medicines, we engage with scientists and physicians around the world in many forums, including academic journals, scientific and medical conventions, and other meetings. 

Occasionally, GSK believes that statements made by others are not fully accurate or don't correctly present information on our medicines.  For example, one Continuing Medical Education presentation contained inaccuracies about data on Avandia soon after the medicine became available to patients. GSK believed it was very important to seek a correction to ensure that the data on Avandia were accurately presented to physicians.  In such situations, it's appropriate for the company to address and try to correct such inaccuracies or misstatements--in fact, we have a responsibility to do that so physicians have the most accurate information available to make the best choice of medicine for their patients.

The health and safety of patients who rely on our medicines is our priority.  Our concern is that inaccuracies in the media will fuel fear and scare diabetic patients into stopping their medicines, with potentially serious health consequences.  GSK stands by the safety and efficacy of Avandia when used appropriately according to its labeling and maintains this is an important medicine for the treatment of Type 2 diabetes. 

Important Safety Information about AVANDIA^® (rosiglitazone maleate)

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin or nitrates is not recommended.

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

·         Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

·         Take insulin or nitrate medicines.

·         Have a type of diabetic eye disease called macular edema.

·         Have liver problems or had liver problems while taking REZULIN^® (troglitazone).

·         Are pregnant or planning to become pregnant.

·         Are breastfeeding or planning to breastfeed.

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

For more information about AVANDIA, please see Medication Guide. For further information on AVANDIA, please see full Prescribing Information.

Today GSK alerted consumers to a potential health risk from long-term excessive use of zinc-containing denture adhesives Super Poligrip 'Original', 'Ultra Fresh' and 'Extra Care'.

While zinc is an essential part of the diet, recent publications suggest that an excessive intake of zinc-containing denture adhesives over several years may lead to the development of neurological symptoms and blood problems such as anemia. Neurological symptoms may include numbness, tingling or weakness in the arms and legs and difficulties with walking and balance.

Super Poligrip is safe to use as directed in the product label. The majority of consumers follow these directions. However, some consumers apply more adhesive than directed and use it more than once per day. Therefore, as a precautionary measure to minimize any potential risks to these consumers, GSK has voluntarily stopped the manufacture, distribution and advertising of these products.  GSK has discussed this situation with the FDA and no further action is required.

What consumers should do

If you have been using zinc-containing Super Poligrip 'Original', 'Ultra Fresh' or 'Extra Care' for several years in greater amounts than directed on the package or more than once per day, or have concerns about your health, you must:

1.     Stop using the product.

2.     Talk to your doctor.

3.     Use a zinc-free alternative such as Super Poligrip 'Free,' Super Poligrip 'Comfort Seal Strips', or Super Poligrip 'Powder'.

People with ill-fitting dentures should seek help from their dental care professional, rather than compensate for poorly fitting dentures by using excessive adhesive. 

Polident Denture Cleanser tablets contain no zinc and are not affected by this announcement.

GSK will soon be introducing zinc-free versions of Super Poligrip 'Original', 'Ultra Fresh' and 'Extra Care'. Zinc Free Formula will be clearly shown on the new packaging.

Consumers with questions may call GSK toll free on 1-866-640-1017.

For GSK to really embrace open innovation, we must first be more open with our intellectual property. Last year, we announced that we would put 800 patents and patent applications into the public domain--commonly known as a 'patent pool'--to help the search for new medicines for neglected tropical diseases. Since we made that announcement, one small company, Alnlyam, has joined us. We hope others will join--and not just companies, but NGOs, not-for-profits, academics.

But our approach will go much further than just patents.  We will allow access to our general "know how" and other knowledge and expertise. In fact we shouldn't call the pool a patent pool--we should call it a knowledge pool, because so much more than just patents are included.

That is why the second element of our open innovation strategy was to create a new concept called the Open Lab which will be part of our Tres Cantos Medicines Development Campus in Spain, dedicated to discovering new medicines for diseases of the developing world.

We are creating capacity for up to 60 outside researchers at our Tres Cantos Campus.  At the Open Lab, researchers will be able to pursue their projects as part of a drug discovery team, allowing these visiting experts to tap into our expertise, facilities, knowledge and industrial-scale infrastructure.  In addition to the resources and benefits-in-kind we are putting into this project, we will also set up a not-for-profit foundation to help fund these research projects, with initial seed funding from us of US$8 million.

This concept has already gained some traction. We are in discussions with two organizations--on projects for malaria and on TB--and we hope to conclude agreements soon and welcome these scientists into the Open Lab.

The third element of our open innovation strategy is to share our malaria drug-development expertise with the world's scientific community. How? Well, we have recently screened our entire compound library for molecules that inhibit the malaria parasite P. falciparum, the deadliest form of malaria found primarily in sub-Saharan Africa. This exercise has identified more than 13,500 'hits' that inhibited the parasite.

Today I am pleased to announce that we commit to put these 13,500 compounds, their chemical structures and associated assay data, into the public domain, making them freely available on leading scientific websites. Over 85% of these are proprietary to GSK. Our hope and expectation is that this will encourage further research by the scientific community on these findings and the opportunities they offer.

We believe that we are the first company to put in the public domain this level of data--and critically these specific chemical structures--from the screening of the entire compound library.  By putting together our compounds, access to our patents and know-how and access to our R&D center and infrastructure we are demonstrating our commitment to R&D for the NTDs.